Hybrid stent

ABSTRACT

A stent includes a high radial force segment and a highly flexible segment, where the diameters of the high radial force segment and the highly flexible segment are substantially the same. The stent may further be placed with an additional stent segment, where the additional stent segment has a radial force similar to the radial force of the highly flexible force segment.

BACKGROUND Field of the Invention

Disclosed herein are stents for implantation within the body and methodsfor delivery and/or deployment. Certain embodiments disclosed herein maybe used in procedures to treat May-Thurner syndrome and/or deep venousthrombosis and the resulting post-thrombotic syndrome.

Description of the Related Art

May-Thurner syndrome, also known as iliac vein compression syndrome, isa condition in which compression of the common venous outflow tract ofthe left lower extremity may cause various adverse effects, including,but not limited to, discomfort, swelling, pain, and/or deep venousthrombosis (DVT) (commonly known as blood clots). May-Thurner syndromeoccurs when the left common iliac vein is compressed by the overlyingright common iliac artery, leading to stasis of blood, which may causethe formation of blood clots in some individuals. Other, less common,variations of May-Thurner syndrome have been described, such ascompression of the right common iliac vein by the right common iliacartery.

While May-Thurner syndrome is thought to represent between two to fivepercent of lower-extremity venous disorders, it frequently goesunrecognized. Nevertheless, it is generally accepted that May-Thurnersyndrome is about three times more common in women than it is in men andtypically manifests itself between the age of twenty and forty. Patientsexhibiting both hypercoagulability and left lower extremity thrombosismay be suffering from May-Thurner syndrome. To confirm that diagnosis,it may be necessary to rule out other causes for hypercoagulable state,for example by evaluating levels of antithrombin, protein C, protein S,factor V Leiden, and prothrombin G20210A.

By contrast to the right common iliac vein, which ascends almostvertically parallel to the inferior vena cava, the left common iliacvein takes a more transverse course. Along this course, it lies underthe right common iliac artery, which may compress it against the lumbarspine. Iliac vein compression is a frequent anatomic variant—it isthought that as much as 50% luminal compression of the left iliac veinoccurs in a quarter of healthy individuals. However, compression of theleft common iliac vein becomes clinically significant only if suchcompression causes appreciable hemodynamic changes in venous flow orvenous pressure, or if it leads to acute or chronic deep venousthrombosis, which will be discussed in more detail below. In addition tothe other problems associated with compression, the vein may alsodevelop intraluminal fibrous spurs from the effects of the chronicpulsatile compressive force from the overlying artery.

The narrowed, turbulent channel associated with May-Thurner syndrome maypredispose the afflicted patient to thrombosis. And, the compromisedblood flow often causes collateral blood vessels to form—most oftenhorizontal transpelvis collaterals, connecting both internal iliac veinsto create additional outflow possibilities through the right commoniliac vein. Sometimes vertical collaterals are formed, most oftenparalumbar, which can cause neurological symptoms, like tingling andnumbness.

Current best practices for the treatment and/or management ofMay-Thurner syndrome is proportional to the severity of the clinicalpresentation. Leg swelling and pain is best evaluated by vascularspecialists, such as vascular surgeons, interventional cardiologists,and interventional radiologists, who both diagnose and treat arterialand venous diseases to ensure that the cause of the extremity pain isevaluated. Diagnosis of May-Thurner syndrome is generally confirmed oneor more imaging modalities that may include magnetic resonancevenography, and venogram, which, because the collapsed/flattened leftcommon iliac may not be visible or noticed using conventionalvenography, are usually confirmed with intravascular ultrasound. Toprevent prolonged swelling or pain as downstream consequences of theleft common iliac hemostasis, blood flow out of the leg should beimproved/increased. Early-stage or uncomplicated cases may be managedsimply with compression stockings. Late-stage or severe May-Thurnersyndrome may require thrombolysis if there is a recent onset ofthrombosis, followed by angioplasty and stenting of the iliac vein afterconfirming the diagnosis with a venogram or an intravascular ultrasound.A stent may be used to support the area from further compressionfollowing angioplasty. However, currently available stenting optionssuffer from several complications—including severe foreshortenting, lackof flexibility (which can force the vessel to straighten excessively),vessel wear and eventual performation, increased load on and deformationof the stent causing early fatigue failure, and/or impedence of flow inthe overlying left iliac artery potentially causing peripheral arterialdisease. The compressed, narrowed outflow channel present in May-Thurnersyndrome may cause stasis of the blood, which an important contributingfactor to deep vein thrombosis.

Some patients suffering from May-Thurner syndrome may exhibit thrombosiswhile others may not. Nevertheless, those patients that do notexperience thrombotic symptoms may still experience thrombosis at anytime. If a patient has extensive thrombosis, pharmacologic and/ormechanical (i.e., pharmacomechanical) thrombectomy may be necessary. Thehemostasis caused by May-Thurner syndrome has been positively linked toan increased incidence of deep vein thrombosis (“DVT”).

Deep vein thrombosis, or deep venous thrombosis, is the formation of ablood clot (thrombus) within a deep vein, predominantly in the legs. Theright and left common iliac are common locations for deep veinthrombosis, but other locations of occurrence are common. Non-specificsymptoms associated with the condition may include pain, swelling,redness, warmness, and engorged superficial veins. Pulmonary embolism, apotentially life-threatening complication of deep vein thrombosis, iscaused by the detachment of a partial or complete thrombus that travelsto the lungs. Post-thrombotic syndrome, another long-term complicationassociated with deep venous thrombosis, is a medical condition caused bya reduction in the return of venous blood to the heart and can includethe symptoms of chronic leg pain, swelling, redness, and ulcers orsores.

Deep vein thrombosis formation typically begins inside the valves of thecalf veins, where the blood is relatively oxygen deprived, whichactivates certain biochemical pathways. Several medical conditionsincrease the risk for deep vein thrombosis, including cancer, trauma,and antiphospholipid syndrome. Other risk factors include older age,surgery, immobilization (e.g., as experienced with bed rest, orthopediccasts, and sitting on long flights), combined oral contraceptives,pregnancy, the postnatal period, and genetic factors. Those geneticfactors include deficiencies with antithrombin, protein C, and proteinS, the mutation of Factor V Leiden, and the property of having a non-Oblood type. The rate of new cases of deep vein thrombosis increasesdramatically from childhood to old age; in adulthood, about 1 in 1000adults develops the condition annually.

Common symptoms of deep vein thrombosis include pain or tenderness,swelling, warmth, redness or discoloration, and distention of surfaceveins, although about half of those with the condition have no symptoms.Signs and symptoms alone are not sufficiently sensitive or specific tomake a diagnosis, but when considered in conjunction with known riskfactors can help determine the likelihood of deep vein thrombosis. Deepvein thrombosis is frequently ruled out as a diagnosis after patientevaluation: the suspected symptoms are more often due to other,unrelated causes, such as cellulitis, Baker's cyst, musculoskeletalinjury, or lymphedema. Other differential diagnoses include hematoma,tumors, venous or arterial aneurysms, and connective tissue disorders.

Anticoagulation, which prevents further coagulation but does not actdirectly on existing clots, is the standard treatment for deep veinthrombosis. Other, potentially adjunct, therapies/treatments may includecompression stockings, selective movement and/or stretching, inferiorvena cava filters, thrombolysis, and thrombectomy.

In any case, treatment of various venous maladies, including thosedescribed above, can be improved with stents. Improvements in stents forvenous use are therefore desired.

BRIEF SUMMARY OF THE INVENTION

Accordingly, the present invention is directed to an intravascular stentthat obviates one or more of the problems due to limitations anddisadvantages of the related art.

In an aspect of the present invention, a stent comprises a first stentsegment, the first stent segment having a first radial force RF1 and afirst diameter D1; and a second stent segment, the second stent segmenthaving a first radial force RF2 and a second diameter D2; whereinRF1>RF2.

In another aspect of the present invention, a stent system comprises afirst stent, comprising a first stent segment, the first stent segmenthaving a radial force RF1 and a diameter D1; and a second stent segment,the second stent segment having a radial force RF2 and a diameter D2;wherein RF1>RF2; an additional stent having a radial force RF4, theadditional stent having an end region configured to overlap a portion ofthe second stent segment in vivo.

Another embodiment includes a method of delivering the stent having afirst segment having a first radial for RF1 and a first diameter D1 anda second segment having a second radial force RF2 and a second diameterD2. The method includes crimping a stent onto a catheter includingradially compressing and lengthening a plurality of rings connected byflexible connectors; placing the first segment at a target location andexpanding the first segment and subsequently placing the second segmentand expanding the second segment wherein RF1>RF2.

Further embodiments, features, and advantages of the intravascularstent, as well as the structure and operation of the various embodimentsof the intravascular stent, are described in detail below with referenceto the accompanying drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory only,and are not restrictive of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, which are incorporated herein and form part ofthe specification, illustrate an intravascular stent. Together with thedescription, the figures further serve to explain the principles of theintravascular stent described herein and thereby enable a person skilledin the pertinent art to make and use the intravascular stent.

FIG. 1 shows an inferior-posterior view of the L5 lumbar and thebifurcations of the abdominal aorta and inferior vena cava;

FIG. 2 shows a schematic of the standard overlap of the right commoniliac artery over the left common iliac vein;

FIG. 3 shows a cross-sectional schematic of the arterio-venous systemshown in FIG. 2;

FIG. 4 illustrates radial force as radial resistive force or chronicoutward force;

FIG. 5 illustrates crush resistance force and load on an exemplarystent;

FIG. 6 illustrates an exemplary hybrid stent according to principles ofthe present disclosure;

FIG. 7 illustrates an exemplary reinforcement ring according toprinciples of the present disclosure;

FIG. 8 illustrates an exemplary embodiment of a hybrid stent accordingto principles of the present disclosure;

FIG. 9A, FIG. 9B and FIG. 9C illustrate details of the embodiment ofFIG. 8.

FIG. 10 illustrates an exemplary placement of a hybrid stent accordingto principles of the present disclosure in the left common iliac vein;

FIG. 11 illustrates an exemplary placement of a hybrid stent having aflared end according to principles of the present disclosure in the leftcommon iliac vein;

FIG. 12 illustrates an exemplary extension stent according principles ofthe present disclosure;

FIG. 13 illustrates an embodiment of an extension stent according toprinciples of the present disclosure; and

FIG. 14 illustrates an exemplary placement of a hybrid stent and anextension stent according to principles of the present disclosure in theleft common iliac vein.

DETAILED DESCRIPTION

Accurate placement is ideal in all medical interventions, but it isvital in areas where the end that is first deployed is critical. Suchareas include at vessel bifurcations and branch vessels, so that theimplant does not enter or interfere with the portion of the vessel thatdoes not require treatment. Such a bifurcation is present at theinferior vena cava where it branches into right and left iliac veins, asdescribed in more detail below.

May-Thurner syndrome, or iliac vein compression syndrome, occurs in theperipheral venous system when the iliac artery compresses the iliac veinagainst the spine as shown in FIG. 1. FIG. 1 illustrates a vertebra, theright and left common iliac arteries near the bifurcation of theabdominal aorta, and the right and left common iliac arteries near thebifurcation of the inferior vena cava. The bifurcations generally occurnear the L5 lumbar vertebra. Thus, it can be seen that FIG. 1 shows aninferior-posterior view of the L5 lumbar and the bifurcations of theabdominal aorta and inferior vena cava.

As shown, the strong right common iliac artery has compressed the iliacvein causing it to become narrowed. This is one possible, if not aclassic, manifestation of May-Thurner syndrome. Over time, suchnarrowing may cause vascular scarring which can result in intraluminalchanges that could precipitate iliofemoral venous outflow obstructionand/or deep vein thrombosis. As discussed above, venous insufficiency(i.e., a condition in which the flow of blood through the veins isimpaired) can ultimately lead to various deleterious pathologiesincluding, but not limited to, pain, swelling, edema, skin changes, andulcerations. Venous insufficiency is typically brought on by venoushypertension that develops as a result of persistent venous obstructionand incompetent (or subcompetent) venous valves. Current treatments forvenous outflow obstruction include anticoagulation, thrombolysis,balloon angioplasty and stenting.

FIG. 2 illustrates the standard overlap of the right common iliac arteryover the left common iliac vein. The arteries shown include theabdominal aorta 1500 branching into the left common iliac artery 1501and the right common iliac artery 1502. The veins shown include theinferior vena cava 1503 branching into the left common iliac vein 1504and right common iliac vein 1505. It will be understood that the roughdiagram illustrated in FIG. 2 represents the view looking down on apatient laying face-up (i.e., an anterior-poster view of the patient atthe location of the bifurcation of the abdominal aorta 1500 and theinferior vena cava 1503). The overlap of the right common iliac artery1502, which is relatively strong and muscular, over the left commoniliac vein 1504 can cause May-Thurner syndrome by pressing down on thevein 1504, crushing it against the spine, restricting flow, and,eventually, causing thrombosis and potentially partially or completelyclotting off of the left common iliac vein 1504 and everything upstreamof it (i.e., the venous system in the left leg, among others).

FIG. 3 illustrates a cross-section of the arterio-venous system shown inFIG. 2 taken along the gray dotted line. Shown in schematic are theright common iliac artery 1600, the left common iliac vein 1601, and avertebra 1602 of the spine (possibly the L5 lumbar vertebra of thelumbar spine). As can be seen, the right common iliac artery 1600 issubstantially cylindrical, due to its strong, muscular construction(among other potential factors). That strong, muscular artery haspressed down on the left common iliac vein 1601, until it has almostcompletely lost patency, i.e., it is nearly completely pinched off. Itwill be understood that May-Thurner syndrome may indeed involve suchsevere pinching/crushing of the underlying left common iliac vein 1601against the vertebra 1602 of the lumbar spine. However, it will also beunderstood that May-Thurner syndrome may involve much lesspinching/crushing of the underlying left common iliac vein 1601 againstthe vertebra 1602. Indeed, embodiments disclosed herein are appropriatefor the treatment of various degrees of May-Thurner syndrome, includingfull crushing/pinching of the left common iliac vein 1602 by the rightcommon iliac artery 1600. Other embodiments disclosed herein areappropriate for the treatment of various degrees of May-Thurnersyndrome, including, but not limited to a crush/pinch of the underlyingleft common iliac vein 1601 of between about 10-95%, about 15-90%, about20-85%, about 25-80%, about 30-75%, about 35-70%, about 40-65%, about45-60%, and about 50-55%, or any other crush/pinch that could merittreatment using one or more of the devices disclosed herein.

Generally, disclosed herein are stents that include circumferentialrings of alternating interconnected struts connected by flexibleconnectors. The stent may have open or closed cells of variousconfiguration formed by an expandable material. The final expandedimplanted configuration can be achieved through mechanicalexpansion/actuation (e.g., balloon-expandable) or self-expansion (e.g.,Nitinol). An exemplary embodiment of the stents described herein areself-expanding implants comprising super elastic or shape memory alloymaterials, but the stent is not so limited and may be formed ofballoon-expandable material. According to an aspect of the presentdisclosure, an expandable stent has varying magnitudes of radial force,crush resistance and flexibility at different locations along the lengthof the stent, while at the same time, the different locations have thesame or similar diameter in an expanded configuration of the stent.

As illustrated in FIG. 6, an exemplary stent 10 includes a high radialforce segment 14, a highly flexible segment 18 and a transition segment22 between the high radial force segment 14 and the highly flexiblesegment 18. The exemplary stent 10, as illustrated in FIG. 6, mayinclude a reinforcement ring 26 at an end of the stent 10, for example,adjacent the highly flexible segment 18 (configuration shown) oradjacent the high radial force segment 14 (configuration not shown). Inan embodiment according to principles described herein, the stent 10having a high radial force segment 14 and a highly flexible segment 18may be cut from a single tube, such as nitinol, for example, but couldalso be formed or cut from flat sheets that are welded together at longedges to form a tube-like structure. While a transition segment isillustrated herein, it should be noted that a hybrid stent that does notinclude a transition segment is considered to be within the scope ofthis disclosure.

Generally radial force refers to both or either Radial Resistive Force(RRF) and Chronic Outward Force (COF). As shown in FIG. 4, radialresistive force is an external force that acts around the circumferenceof a stent on the stent (toward the center of the stent). Chronicoutward force is the force the sent exerts outward from a direction ofthe center of the stent. Chronic outward force of a stent will cause thestent to exert force on the vessel in which it is inserted to resistcollapse and keep the vessel open. FIG. 5 illustrates crush resistance,as used herein. Crush resistance is a force of the stent when subject toa flat plate/focal crush load. While the radial force vector directionsin FIG. 6 illustrate chronic outward force, the radial force accordingto principles of the present disclosure may be radial resistive force,which is more related to crush resistance than a chronic outward force.Vectors illustrated in the figures are meant to indicate direction, notmagnitude. Although Radial Force and Crush Resistance can be relatedthey do not necessarily drive each other. So a stent may be designed tohave high crush resistance (flat plate/focal) but not high radial force.Such attributes can be tested independently in different testconfigurations.

The reinforcement ring may be an area of greater stiffness/crushresistance at an end portion of the stent. “Greater stiffness” heremeans having a stiffness/crush resistance greater than a portion of thestent adjacent the reinforcement ring. The reinforcement ring havinggreater stiffness may provide good inflow into the stent and through thevessel having the implant therein. While described herein as a“reinforcement ring,” the area of greater stiffness may be provided byan additional structure overlying the stent end (e.g., a “ring”) or mayinstead be an area where the strut structure is actually stronger, e.g.because the material forming the area of greater stiffness is inherentlystiffer, a tighter cell structure, thicker struts or the like. Forexample, the reinforcement ring may have a different stent geometry,e.g., different strut width or is simply a fully-connected ring.

An exemplary embodiment of the reinforcement ring is illustrated in FIG.7. As can be seen in FIG. 7, more of the ring struts making up thereinforcement ring are connected by flexible connectors/bridges to theadjacent ring than in the neighboring highly flexible segment.

Returning to the stent structure, as illustrated in FIG. 6, a length ofstent 10 having length L0 includes high radial force segment 14 having aradial force and/or crush resistance RF1 and a flexibility F1 along thelength L1 of the high radial force segment 14. That is, a radialresistive force RF1 of the high radial force segment 14 is relativelygreater than the remainder of the stent 10, and may be in the range of0.75 to 1.00 N/mm, for example. The flexibility F1 of the high radialforce segment 14 may also be relatively lower than the remainder of thestent 10. Flexibility is evaluated/measured through angle of deflection.According to principles described herein, the high radial force segmentmay be designed to withstand long term durability (fatigue) testing witha flexion range of 0-60 degrees.

The relatively high radial force segment 14 is intended to be placed ina vessel in the region of the vessel prone to compression or crushing,such as pinching/crushing of the underlying left common iliac vein 1601against the vertebra 1602 caused by May-Thurner syndrome, as illustratedin FIG. 3. The high radial force segment has a diameter D1.

The length of stent L0 also includes a highly flexible segment 18, whichhas relatively greater flexibility than the high radial force 14 segmentalong the length of the highly flexible segment 18. In addition,according principles of the present disclosure, the highly flexiblesegment 18 has a length L2, a diameter D2 and radial force, crushresistance RF2 and flexibility F2, where RF2<RF1 and F2>F1, such thatthe highly flexible segment is more flexible than the high radial forcesegment 14. According to principles described herein, the highlyflexible segment may be designed to withstand long term durability(fatigue) testing with a flexion range of 0-140 degrees. A radialresistive force RF2 of the highly flexible segment 18 may be in therange of 0.50 to 0.70 N/mm, for example.

The length of stent 10 may also include a transition segment 22 betweenthe high radial force segment 14 and the highly flexible segment 18,where the transition segment 22 has a length L3, a diameter D3 andradial force or radial resistive force (crush resistance) RF3 andflexibility F3, where RF1>RF3>RF2 and F1 and F2>F3>F1. The radial forceor radial resistive force (crush resistance) RF3 and flexibility F3 ofthe transition segment 22 may vary over the length L3 of the transitionsegment 22 or may be constant along the length L3 of the transitionsegment 22.

Each of the high radial force segment 14, transition segment 22 andhighly flexible segment 18 has a different radial force, crushresistance and flexibility, which may be provided by different ringstructures in each segment of the stent 10. As can be observed in FIG.6, a high radial force segment 14 may have a cell structure that hasrelatively greater periodicity, may be formed of stiffer ring struts andflexible connectors, and/or may have a more closed cell structure orother structure to impart the desired radial force or crush resistancerelative to the radial force or crush resistance of the highly flexiblesegment. For example, the strut geometry, thicker/wider struts providemore radial strength, number of apexes around the circumference of thestent/ring geometry can all drive radial force up or down, and theconfiguration/connection to the adjacent rings through the bridgeconnectors and more ring connectors can increase radial force.Similarly, the highly flexible segment 18 may have a cell structure thathas relatively lesser periodicity, may be formed of relatively moreflexible ring struts and flexible connectors, and/or have a more opencell structure. The transition segment may have a cell structure thattransitions a geometry of the rings struts and flexible connectors ofthe high radial force segment to a geometry of the highly flexiblesegment, or the transition segment may have a different cell structurethan the high radial force segment and the highly flexible segment. Inan embodiment according to principles described herein, the stent havinga high radial force segment, a transition segment and a highly flexiblesegment may be cut from a single tube, such as nitinol, for example, butmay also be formed by any other suitable means.

In the illustrated embodiment of FIG. 6, each of the segments of thestent has substantially the same diameter, such that D1≈D2≈D3. Asdescribed herein, one stent can treat a range of vein vessel diameters.The present stent structure may allow a single stent to treat multiplevessel sizes as the force exerted on the vessel remains fairlyconsistent over a range of diameters (3-4 mm). This is different thanconventional stents in that most conventionally stents need to bespecifically sized to the vessel they are treating (i.e., 0.5 mm-1.0 mmof oversizing). Thus, most conventional stents are offered in 2 mmincrements (e.g., 10 mm, 12 mm, 14 mm, etc.). Adaptive diameteraccording to principles described herein simplifies sizing decisions forthe doctor and allows a single stent to treat a long segment of vein, asthe vein diameter generally reduces in diameter in the proximaldirection.

It is contemplated that the length L2 of the highly flexible segment 18will be greater than the length L1 of the high radial force segmentwhich will be greater than the length L3 of the transition segment.

An exemplary embodiment structure of a stent 110 according to principlesof the present disclosure is shown in FIG. 8. As illustrated in FIG. 8,the diameter DS along the stent 110 at any given ring 112 issubstantially the same (D1≈D2≈D3). In the embodiment illustrated in FIG.8, each of the high radial force segment (May-Thurner Syndrome “MTS”Section) 114, the transition segment (Transition Section) 122 and thehighly flexible segment (Main Body Section) 118, has a similar cellpattern. In such case, the radial force or crush resistance RF of thesegments may be varied by varying the thickness of the struts and/orflexible connectors 132 or the angular relationship of the struts withother struts and/or with the flexible connectors and/or the angulationof the flexible connectors themselves.

It should be noted that terms such as perpendicular, thickness, same,similar, and other dimensional and geometric terms should not beregarded as strict or perfect in their application. Instead, geometricand other dimensional reference terms should be interpreted based ontheir correspondence to accepted manufacturing tolerances and functionalneeds of the stent 110 on which they are employed. For example, the term“perpendicular” should be appreciated as affording a reasonable amountof angular variation due to manufacturing imperfections or the actualintentional curves cut or formed in the stent design 110. Also, anythickness, width or other dimension should be assessed based ontolerances and functional needs of the design rather than idealizedmeasurements.

The thickness of the strut 128, on the other hand, is its depth in theradial direction which is generally perpendicular to the strut widthmeasurement, as shown in FIG. 8. The strut thickness 128 normallycorresponds to the wall thickness (outside diameter minus insidediameter) of the tube from which the stent 110 is laser cut afteretching, grinding and other processing. But, embodiments of the stentsdisclosed herein are not necessarily limited to being laser-cut from acylindrical tube with a predetermined wall thickness. They could also beformed or cut from flat sheets that are welded together at long edges toform a tube-like structure.

Each of the rings 112 is comprised of a plurality of ring struts 128interconnected to form alternating peaks or apexes 120 and troughs 124.As shown in FIG. 8, each of the ring struts 128 is generally straight.In one embodiment shown in FIGS. 8-9, a stent 110 includes a pluralityof rings 112 connected by a plurality of flexible connectors 132. Therings 112 are arranged in a spaced relationship along a long axis 116 ofthe stent 110. The connectors 132 extend between adjacent pairs of therings 112. Each of the rings 112 and connectors 132 are comprised of aplurality of interconnecting struts. The dimensions and orientation ofthese struts are designed to provide flexibility and radial stiffnessaccording to principles of the present disclosure.

The exemplary hybrid stent 110 illustrated in FIG. 8 may be made ofNitinol tubing that is superelastic per ASTM F2063. The stentspecification may further be as follows, post eletropolishing: AFtemperature of parts to be 19+/−10 degrees Celsius. The hybrid stent maybe designed to treat a range of iliofemoral veins ranging in size from12 mm to 20 mm. These dimensions are exemplary and a stent according toprinciples of the present disclosure are not so limited.

FIGS. 9A, 9B and 9C illustrate details of the strut and connectorstructure of the high radial force segment 114 (FIG. 9A) and the highlyflexible segment 118 (FIG. 9B) of the embodiment FIG. 8 at the locationsindicated in FIG. 8. FIG. 9C is showing detailed dimensions of theeyelet 119 geometry in which a radiopaque (RO) marker will be insertedto aid the doctor with deployment location of the stent underfluoroscopy.

FIG. 9A illustrates ring struts 128 a of the high radial force segment114. FIG. 9B illustrates ring struts 128 b of the highly flexiblesegment 118.

As can be appreciated, foreshortening of the stent can be a particularproblem for placement of a stent. In practice, stents with greaterflexibility tend to foreshorten more. As discussed above, accurateplacement is ideal in all medical interventions, but it is of greatinterest in areas where the end that is first deployed is critical. Suchareas include at vessel bifurcations and branch vessels, so that theimplant does not enter or interfere with the portion of the vessel thatdoes not require treatment. Such a bifurcation is present at theinferior vena cava where it branches into right and left iliac veins, asdescribed in more detail below.

As described herein, a stent according to principles described hereinincludes a high radial force segment and a highly flexible segment. Thehigh radial force segment, with its stiffer structure, will foreshortenless than the highly flexible segment, and as a result, can allow formore accurate placement in the vessel into which it is implanted. FIG.10 illustrates a rough placement of a stent according to principles ofthe present disclosure. FIG. 10 illustrates the inferior vena cava 1503branching into the left common iliac vein 1504 and right common iliacvein 1505. It will be understood that the rough diagram illustrated inFIG. 10 represents the view looking down on a patient laying face-up(i.e., an anterior-poster view of the patient at the location of thebifurcation of the inferior vena cava 1503). For sake of simplicity, theabdominal aorta and its branching are not shown in FIG. 10, but areshown in FIG. 2, above.

As illustrated in FIG. 10, a multi-segment stent 10 according toprinciples described is placed in the left common iliac vein 1504. Thehigh radial force segment 14 of the stent 10 may be allowed to extendinto the iliac vein 1503, although the end of the high radial forcesegment is intended to be placed to be at the junction of the leftcommon iliac vein 1504 and the iliac vein 1503. The highly flexiblesegment 18 extends away from the high radial force segment 14 and thetransition segment 22 between the highly flexible segment 18 and thehigh radial force segment 14.

To facilitate placement of the stent 10 at the junction of the leftcommon iliac vein 1504 and the iliac vein 1503, the stent 10 may have aflared end adjacent the high radial force segment 14, as illustrated inFIG. 11. The distal flared section is controlled by radius ‘r’.Exemplary flare sizes include 2.5 mm×5.0 mm and 5.0 mm×5.0 mm, but stentflares according to principles of the present disclosure are not solimited. The flared distal end of the stent may be used for placement ofthe stent at a bifurcation of two vessels such as the common iliac vein1504 and the iliac vein 1503. The pre-loaded stent configuration on thedelivery system described herein allows the distal flared section of thestent to be partially deployed from the delivery system allowing theoperator to position the flared section of the stent at the bifurcationof two vessels. The delivery catheter is advanced central to the vesselbifurcation to be treated, in this case the left common iliac vein 1504.If radiopaque markers are provided on the implant, the operator can seatthe partially deployed flare section of the stent at the bifurcationjunction using the radiopaque markers. Once the central flared end ofthe partially deployed stent is in the appropriate deployment locationand seated at the bifurcation junction the remainder of the stent can bedeployed.

In an aspect of the present invention, a separate extension stent 50 maybe included along with the stent 10. An embodiment of the separateextension stent 50 is illustrated in FIG. 12. As illustrated in FIG. 12,the separate extension stent 50 is tubular and may be a highly flexiblesegment similar to the highly flexible segment 18 in the hybrid stent 10described above. In an aspect of the present disclosure, the separateextension stent 50 may comprise a plurality of rings 152, which comprisea plurality of ring struts 158 interconnected to form alternating peaksor apexes 160 and troughs 164. As shown in FIG. 12, each of the ringstruts 158 is generally straight. The ring struts 158 may be connectedto flexible connectors 162. The rings 152 are arranged in a spacedrelationship along a long axis 116 of the stent 110. The connectors 162extend between adjacent pairs of the rings. The separate extension stent50 may also include reinforcement rings on either or both ends of thetube. The dimensions and orientation of these struts are designed toprovide flexibility and radial stiffness according to principles of thepresent disclosure. Each of the rings 152 and connectors 162 comprises aplurality of interconnecting struts. The separate extension stent ismade of an expandable material or a self-expandable material, such asNitinol. The separate expansion stent 50 may be cut from a single tube,such as nitinol, for example, but could also be formed or cut from flatsheets that are welded together at long edges to form a tube-likestructure.

An exemplary extension stent is illustrated in FIG. 13. The extensionstent illustrated in FIG. 13 may be made of nitinol tubing that issuperelastic per ASTM F2063. The stent specification may further be asfollows, post electropolishing: AF temperature of parts to be 19+/−10degrees Celsius. The extension stent may be designed to treat a range ofiliofemoral veins ranging in size from 8 mm to 16 mm. These dimensions,as well as dimensions illustrated in the figures, are exemplary and astent according to principles of the present disclosure are not solimited.

The separate extension stent 50 is placed in the left iliac vein 1504adjacent the highly flexible segment 18 of the hybrid stent 10 and mayoverlap the end of hybrid stent 10, as illustrated in FIG. 14. Theregion of overlap in the illustration is indicted by reference number200. The placement of the hybrid stent 10 and the separate extensionstent 50 may be performed using the same delivery device at the sametime. A second delivery catheter with pre-crimped extension stent may beintroduced into the treatment vessel and approximate the proximal end ofthe previously deployed hybrid stent. The catheter with crimpedextension stent would be inserted into the proximal end of the hybridstent, positioned and the stent would be deployed utilizing theradiopaque markers on both stents to achieve appropriate overlap, e.g.,1 cm. In another aspect, the extension stent can be implanted as astand-alone stent.

It should be noted that an extension stent as described herein may beused in combination with other stents as a “main stent”, besides thehybrid stent 10. In use, the extension stent can be used to allow forvariation in placement.

In addition, the extension stent may include reinforcement rings wherethe reinforcement ring may be an area of greater stiffness/crushresistance at an end portion of the stent. “Greater stiffness” heremeans having a stiffness greater than a portion of the sent adjacent thereinforcement ring. The reinforcement ring having greater stiffness mayprovide good inflow into the stent and through the vessel having theimplant therein. The reinforcement rings may make the extension stenteasier to place with respect to the main stent, for example, bymitigating crushing of the ends as they are made to overlap. Inaddition, to facilitate placement, the ends of the extension stentand/or the stent to which it is to be placed adjacent can be coated witha polymer, such as urethane or PTFE. Also, the extension stent mayinclude anchors, eyelets, radiopaque markers or other features to assistin placement of the extension stent. The extension stent may also bedelivered with the main stent, or may be separately delivered to thevessel.

The extension stent may be delivered via an appropriate access site,(e.g. jugular, popliteal, etc.). The extension stent can be made to be“bidirectional”, such that it could be preloaded onto a deliverycatheter without specific regard to the direction of the delivery (e.g.,jugular, popliteal, etc.). E.g. the delivery can be made from above thetreatment region or from below the treatment region. Suchbidirectionality can be facilitated by the extensions stent geometrybeing symmetrical such that ends of the extension stent have the samegeometry. The stent may be delivered by a coaxial delivery catheter. Inanother aspect of the present disclosure, a novel delivery device mayinclude a cartridge that may be loaded onto a catheter and the hybridsent also loaded on the catheter. The cartridge can be flipped by theoperator for retrograde or anterograde. The stent may be preloaded ontothe delivery catheter for the direction of the delivery (e.g., jugular,popliteal, etc.)

As can be appreciated, the actual stent ring geometry may vary from thatdisclosed herein, as long as the stent 10 includes a first section witha relatively higher radial force or crush resistance than a secondsection of the stent that has a relatively higher flexibility than thefirst section. It is also contemplated that the separate extension stent50 have a flexibility similar to the highly flexible segment of thehybrid stent 10. Exemplary stent geometries for segments of the hybridstent 10 and the extension stent 50 are taught in U.S. patentapplication Ser. Nos. 15/471,980 and 15/684,626, which are herebyincorporated by reference for all purposes as if fully set forth herein.

For example, it is noted that the struts of the rings and flexibleconnectors with structure, including areas of expanded or reduced widthor thickness, to account for venous applications may be used. As anotherexample, it is noted that venous applications benefit fromconfigurations that improve flexibility (due to the greater elasticityof venous applications) while maintaining enough stiffness to resistpressure on the venous structure in selected areas (such as for theMay-Thurner syndrome).

Notably the stents herein are not necessarily limited to venousapplications unless specifically required by the claims. The disclosedstents could be employed in arterial and biliary applications, forexample. But, are particularly suited for the demands of relatively softstructures defining lumens that are subject to much greater bending,twisting, stretching and other contortions and loads than are generalarterial lumens.

To deploy the implant, the implant may be radially compressed/crimped toa smaller diameter for loading onto/into a delivery catheter. Theimplant may be crimped over a balloon on the inner core of the deliverysystem which may be later inflated to expand the crimped implant to thedesired diameter.

Implants such as those described above may advantageously provide anadaptive diameter and/or flexibility to conform the dynamic movement ofperipheral veins in leg/pelvis thereby facilitating treatment of bothiliac vein compression syndrome and iliofemoral venous outflowobstructions.

It may be desirable to have a stent that will conform to the existingpath of a vein instead of a straightening out of the vessel by thestent. It may also be desirable to have a high radial stiffness of thestent to resist collapse of the stent under crushing load and tomaximize the resultant diameter of the treated vessel at the location ofthe stent deployment. With most stent constructions there is a directrelationship between radial stiffness and axial stiffness.

Common commercially available balloon expandable stents experience adramatic change in length as a balloon is used to expand the stentwithin the vessel. Common commercially available self-expanding stentsexperience a change in length less dramatic, but still substantial,which increases with increasing stent length. Change in length betweenthe configuration within the delivery system and when deployed in thevessel causes difficulty in placing/landing the stent precisely at thetarget location. When the stent is delivered in its crimpedconfiguration, then deployed or expanded, the shortening in lengthcauses the stent target deployment location to have to offset from thetarget dwell location. The magnitude of this effect is not controllableor easily anticipated as it is dependent on the luminal cross-sectionalong the length of the target dwell location (which is frequently andunexpectedly influenced by residual stenosis, irregular shape due toexternal objects, and/or forces, etc.). For target lesions leading up tothe junction of the left and right iliac into the IVC, this causesdifficulty in placing the stent to dwell completely within the iliacalong its total length up to the junction to the inferior vena cavawithout crossing into the inferior vena cava. Placement of a high radialforce segment at the junction not only assists in addressing crush byMay-Thurner Syndrome, but also may assist in reducing foreshorteningfrom the target location.

Embodiments disclosed herein can be used for both balloon expandable andself-expanding stent designs. The stent designs can be used for allstent interventions, including coronary, peripheral, carotid, neuro,biliary and, especially, venous applications. Additionally, this couldbe beneficial for stent grafts, percutaneous valves, etc.

Currently available implants are typically loaded and retained onto adelivery system in a crimped configuration and then navigated anddeployed in the desired anatomical location where they expand to theimplanted configuration. The final implanted configuration can beachieved through mechanical expansion/actuation (e.g.,balloon-expandable) or self-expansion (e.g., Nitinol). Self-expandingimplants are manufactured from super elastic or shape memory alloymaterials. Accurate and precise deployment of a self-expanding implantcan be challenging due to a number of inherent design attributesassociated with self-expanding implants. The implant may jump/advancefrom the distal end of the delivery system during deployment due to thestored elastic energy of the material. Additionally, the implant mayforeshorten during deployment due to the change in the implant diameterfrom the crimped configuration to the expanded configuration. Finally,physiological and anatomical configurations, such a placement at or nearbifurcations of body lumens, can affect accurate placement of implants.Once the implant is placed within the body lumen there is potential foruneven expansion or lack of circumferential implant apposition to thebody lumen which can result in movement, migration or in certain severecases implant embolization.

In some embodiments, a self-expanding implant designed with sufficientradial force or crush resistance to resist constant compression of thebody lumen while providing optimal fatigue resistance, accurateplacement, and in-vivo anchoring to prevent movement/migration isprovided. Additionally, various methods for deployment and implantationfor treating iliac vein compression syndrome and venous insufficiencydisease are provided.

In some embodiments, the implant comprises a purposely designed venousimplant intended to focally treat iliac vein compression (May-ThurnerSyndrome). The implant may be relatively short in length (˜60 mm) andmay be manufactured from self-expending Nitinol with integrated anchorfeatures to aid in accurate placement and to mitigate migrationfollowing implantation. The implant and delivery system are designed forprecise deployment and placement at the bifurcation of the inferior venacava into the right and left common iliac veins.

As another feature, the stents disclosed herein can include anchormembers, radiopaque markers, or eyelets, for example, set forth inpending U.S. patent application Ser. Nos. 15/471,980 and 15/684,626,which are hereby incorporated by reference for all purposes as if fullyset forth herein.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

Similarly, this method of disclosure, is not to be interpreted asreflecting an intention that any claim require more features than areexpressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing the Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. It will be apparent to persons skilledin the relevant art that various changes in form and detail can be madetherein without departing from the spirit and scope of the presentinvention. Thus, the breadth and scope of the present invention shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims and theirequivalents.

1. An expandable, intraluminal stent, comprising: a plurality of ringsconnected to one another to form a series of said rings, the ringscomprising a plurality of ring struts, the ring struts comprising shapememory alloy, the ring struts connected such that each of the pluralityof rings comprises a sinusoidal pattern, the rings having a firststiffness and a first crush resistance; and at least one reinforcementring comprising shape memory alloy at an end of the series of theplurality of rings such that the at least one reinforcement ring is theend ring of said stent, the reinforcement ring having a second stiffnessand a second crush resistance.
 2. The expandable, intraluminal stent ofclaim 1, wherein the at least one reinforcement ring has a higher radialforce than one of said rings.
 3. The expandable, intraluminal stent ofclaim 1, wherein the second crush resistance is greater than the firstcrush resistance.
 4. The expandable, intraluminal stent of claim 1,wherein the second stiffness is greater than the first stiffness.
 5. Theexpandable, intraluminal stent of claim 1, wherein the at least onereinforcement ring comprises additional structure overlying one of theplurality of rings.
 6. The expandable, intraluminal stent of claim 5,wherein the additional structure comprises a plurality of additionalstruts.
 7. The expandable, intraluminal stent of claim 1, wherein the atleast one reinforcement ring comprises a plurality of reinforcement ringstruts, wherein the reinforcement ring struts have greater stiffnessthan the ring struts.
 8. The expandable, intraluminal stent of claim 1,wherein each of said rings comprises a first strut geometry, and whereinthe at least one reinforcement ring comprises a second strut geometry,wherein the first geometry is different than the second strut geometry.9. The expandable, intraluminal stent of claim 1, wherein each of saidrings comprises a plurality of first cells formed by the ring struts andthe at least one reinforcement ring comprises a plurality of secondcells, wherein a number of said second cells is greater than a number ofsaid first cells.
 10. The expandable, intraluminal stent of claim 1,further comprising a plurality of flexible connectors connecting theplurality of rings in the series.
 11. The expandable, intraluminal stentof claim 10, wherein the at least one reinforcement ring comprises aplurality of additional struts.
 12. The expandable, intraluminal stentof claim 10, wherein the at least one reinforcement ring is attached toan adjacent one of said rings by a plurality of said flexibleconnectors.
 13. The expandable, intraluminal stent of claim 12, whereina number of flexible connectors attaching the at least one reinforcementring to the adjacent one of said rings is greater than a number offlexible connectors connecting a first one of said rings in the serieswith a second one of said rings the series.
 14. The expandable,intraluminal stent of claim 1, wherein the at least one reinforcementring comprises a ring in the series having additional ring struts. 15.The expandable, intraluminal stent of claim 1, wherein the at least onereinforcement ring is coated with a polymer.
 16. The intraluminal stentof claim 1, wherein the interconnected struts of a respective one of theplurality of circumferential rings are unitary.
 17. An intraluminalstent, comprising: a plurality of circumferential rings having a firstradial force and comprising a first plurality of interconnected strutsconnected in a sinusoidal pattern, the first plurality of interconnectedstruts comprising shape memory alloy; a plurality of flexible connectorsconnecting adjacent circumferential rings to form an expandable tube;and a reinforced end ring at an end region of the expandable tube andcomprising a second plurality of alternating interconnected struts, thesecond plurality of interconnected struts comprising shape memory alloy,the reinforced end ring having a second radial force different from thefirst radial force.
 18. The intraluminal stent of claim 17, wherein eachof said circumferential rings comprises a plurality of first cellsformed by the interconnected struts and the reinforced end ringcomprises a plurality of second cells, wherein a number of said secondcells is greater than a number of said first cells.
 19. The intraluminalstent of claim 17, wherein the reinforced end ring comprises one of theplurality of circumferential rings and additional structure overlyingthe interconnected struts of the one of the plurality of circumferentialrings.
 20. The intraluminal stent of claim 17, wherein the reinforcedend ring is adjacent to and connected to only one of the circumferentialrings.
 21. The intraluminal stent of claim 20, wherein the reinforcedend ring is attached to the adjacent circumferential ring by a pluralityof said flexible connectors.
 22. The intraluminal stent of claim 21,wherein a number of flexible connectors attaching the reinforced endring to the adjacent circumferential ring is greater than a number offlexible connectors connecting a first one of said rings in the serieswith a second one of said rings the series.
 23. The intraluminal stentof claim 17, wherein the reinforced end ring comprises one of theplurality of circumferential rings in the series having additionalinterconnected struts.
 24. The intraluminal stent of claim 17, whereinthe reinforcement ring is coated with a polymer.
 25. The intraluminalstent of claim 17, wherein the interconnected struts of a respective oneof the plurality of circumferential rings are unitary.
 26. Theexpandable, intraluminal stent of claim 17, wherein each of said ringscomprises a first strut geometry and the reinforced end ring comprises asecond strut geometry, wherein the first geometry is different than thesecond strut geometry.
 27. An expandable, intraluminal stent,comprising: a first stent segment, the first stent segment having afirst radial force RF1 and a first diameter D1; a second stent segment,the second stent segment having a second radial force RF2 and a seconddiameter D2; wherein RF1>RF2; and at least one reinforcement ring at anend of one of the first stent segment and an end of the second stentsegment, the reinforcement ring having a reinforcement ring radialforce, wherein reinforcement ring radial force is greater than RF2.